Interfant-99
A treatment protocol for infants younger than 1 year with acute lymphoblastic leukaemia (Interfant-99): an observational study and a multicentre randomised trial
Phase 3N = 482NCT00015873
- Population
- Infants aged 0-12 months with acute lymphoblastic leukaemia (482 treated with the hybrid regimen).
- Design
- International study by 17 study groups in 22 countries (1999 to 2005). Risk stratification by peripheral blood response to a 7-day prednisone prophase, then a hybrid regimen based on a standard ALL protocol with elements for AML treatment. Before maintenance, a subset of patients in complete remission was randomly assigned to standard treatment or an intensified course of high-dose cytarabine and methotrexate. Primary outcomes: EFS (initial cohort) and DFS (randomised patients); intention-to-treat analysis.
- Primary endpoint
- EFS, DFS
- Arms
- Hybrid protocol (all treated infants) (experimental, n = 482): Hybrid ALL/AML regimen after a 7-day prednisone prophase
- Randomised: late intensification (experimental, n = 95): Intensified course of high-dose cytarabine and methotrexate before maintenance
- Randomised: control (control, n = 96): Standard treatment before maintenance
- People
- Pieters R, senior author Valsecchi MG, Interfant study groups
Δ 48-month DFS+3.9 points
Show the numbers
| Endpoint | Analysis | Hybrid protocol (all treated infants) / Randomised: late intensification | Randomised: control | Effect |
|---|---|---|---|---|
| EFS482 enrolled patients who received hybrid treatmentEvent-free survival at 4 years in the initial cohort (primary outcome) | primarymedian follow-up 38 monthsPieters 2007 | 47% at 4 y (41.9–52.1%) | — | Standard error 2.6. Median follow-up 38 months (range 1-78); 260 patients (58%) were in complete remission at that point. |
| DFS191 patients randomised among 445 in complete remission after 5 weeks of induction; intention-to-treat as stated in the abstractDisease-free survival at 4 years in randomised patients (primary outcome) | primarymedian follow-up 42 monthsPieters 2007 | 60.9% at 4 y | 57% at 4 y | P=0.81Standard errors 5.2 and 5.5. Median follow-up 42 months (range 1-73). |
| Endpoint | Analysis | Hybrid protocol (all treated infants) / Randomised: late intensification | Randomised: control | Effect |
|---|---|---|---|---|
| EFS482 enrolled patients who received hybrid treatmentEvent-free survival at 4 years in the initial cohort (primary outcome) | primarymedian follow-up 38 monthsPieters 2007 | 47% at 4 y (41.9–52.1%) | — | Standard error 2.6. Median follow-up 38 months (range 1-78); 260 patients (58%) were in complete remission at that point. |
| DFS191 patients randomised among 445 in complete remission after 5 weeks of induction; intention-to-treat as stated in the abstractDisease-free survival at 4 years in randomised patients (primary outcome) | primarymedian follow-up 42 monthsPieters 2007 | 60.9% at 4 y | 57% at 4 y | P=0.81Standard errors 5.2 and 5.5. Median follow-up 42 months (range 1-73). |